A lower dose formulation of Bayer and Janssen’s bloodthinner Xarelto has been approved by European regulators for preventing recurrent venous thromboembolism, expanding treatment options for patients.
In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.
AbbVie, a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. , announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain.
The U.S. Food and Drug(FDA) Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
The FDA has cleared Abbott’s smartphone-compatible insertable cardiac monitor (ICM), the first and only device of its kind in the U.S. This provides patients and physicians with another way to monitor and diagnose abnormal heart rhythms.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon® BCise™ (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.
Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection. Tafinlar in combination with Mekinist is in development to become the first adjuvant treatment specifically for melanoma patients with a BRAF V600 mutation.
GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
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